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Background <p>Agitation is one of the most distressing neuropsychiatric symptoms in patients with dementia due to Alzheimer’s disease (AD), significantly impacting patients’ quality of life and increasing caregiver burden. Brexpiprazole, a serotonin-dopamine modulator, shows promise for managing agitation. This meta-analysis evaluates the efficacy and safety in managing agitation associated AD.</p> Method <p>A comprehensive literature search was conducted across PubMed, Cochrane, Scopus, Embase and ClinicalTrials.gov from inception until January 2025. We pooled dichotomous outcomes as risk ratios (RR) and continuous outcomes as mean differences (MD) with 95% confidence intervals (CI), using random-effects models. Heterogeneity was assessed using I² and X² statistics. A p-value of &lt; 0.05 was considered statistically significant. All the calculations were performed using RevMan 5.4.</p> Result <p>This meta-analysis included 4 studies involving 1440 patients (944 vs. 496) suffering from agitation associated with dementia in AD. Brexpiprazole significantly reduced agitation on CMAI (MD: -3.94 [-6.21 to -1.67], <i>p</i> &lt; 0.001) and NPI-NH (MD: -0.67 [-1.08 to -0.26], <i>p</i> = 0.002) with optimal efficacy at 2–3&#xa0;mg/day. SAS scores worsened slightly (MD: 0.38 [0.18–0.58], <i>p</i> = 0.0002) while MMSE (<i>p</i> = 0.06) and CGI-S (<i>p</i> = 0.06) remained stable. No significant differences emerged in serious adverse events, mortality, dizziness, or extrapyramidal effects (all <i>p</i> &gt; 0.05).</p> Conclusion <p>Brexpiprazole effectively reduces agitation in AD without major safety concerns, though mild motor effects were noted. Study limitations include moderate heterogeneity and short trial durations. Future research should explore long-term outcomes and patient stratification.</p>

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Dose-Dependent efficacy and safety of Brexpiprazole in agitation associated with dementia in Alzheimer’s disease: A systematic review and meta-analysis

  • 期刊论文

  • 发表日期：

    2026年1月29日

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  • Hammad Javaid,
  • Anurag Jha,
  • Umaima Cheema,
  • Meeram Noor,
  • Shamikha Cheema,
  • Mahnoor Arfan,
  • Maryyam Aqeel,
  • Erum Habib,
  • Muhammad Nabeel Saddique,
  • Maria Qadri,
  • Sheena Shamoon

摘要

Background

Agitation is one of the most distressing neuropsychiatric symptoms in patients with dementia due to Alzheimer’s disease (AD), significantly impacting patients’ quality of life and increasing caregiver burden. Brexpiprazole, a serotonin-dopamine modulator, shows promise for managing agitation. This meta-analysis evaluates the efficacy and safety in managing agitation associated AD.

Method

A comprehensive literature search was conducted across PubMed, Cochrane, Scopus, Embase and ClinicalTrials.gov from inception until January 2025. We pooled dichotomous outcomes as risk ratios (RR) and continuous outcomes as mean differences (MD) with 95% confidence intervals (CI), using random-effects models. Heterogeneity was assessed using I² and X² statistics. A p-value of < 0.05 was considered statistically significant. All the calculations were performed using RevMan 5.4.

Result

This meta-analysis included 4 studies involving 1440 patients (944 vs. 496) suffering from agitation associated with dementia in AD. Brexpiprazole significantly reduced agitation on CMAI (MD: -3.94 [-6.21 to -1.67], p < 0.001) and NPI-NH (MD: -0.67 [-1.08 to -0.26], p = 0.002) with optimal efficacy at 2–3 mg/day. SAS scores worsened slightly (MD: 0.38 [0.18–0.58], p = 0.0002) while MMSE (p = 0.06) and CGI-S (p = 0.06) remained stable. No significant differences emerged in serious adverse events, mortality, dizziness, or extrapyramidal effects (all p > 0.05).

Conclusion

Brexpiprazole effectively reduces agitation in AD without major safety concerns, though mild motor effects were noted. Study limitations include moderate heterogeneity and short trial durations. Future research should explore long-term outcomes and patient stratification.